Objective: We report the results of a pilot clinical study that evaluated the safety and efficacy of a newly-developed, retrievable flow diverter (FloWise; Taewoong Medical) for the treatment of internal carotid artery (ICA) aneurysm. Materials and Methods: A total of 10 patients were enrolled. Inclusion criteria were 1) unruptured aneurysm with a dome size of ≥ 8 mm and a neck size of ≥ 4 mm at the ICA, or 2) two or more unruptured aneurysms of any size able to be spanned by a single FloWise at the ICA. Co-primary effectiveness end points were technical success of FloWise placement, and a 50% or greater decrease in aneurysm volume at the 6-month follow-up angiogram. The primary safety end point was the new development of neurological deficits persisting for more than 1-month post-treatment. Results: Ten patients harboring 14 ICA aneurysms (median diameter, 9.4 mm; range, 2.3-31.0 mm) were enrolled between January 2016 and July 2017. FloWise placement was successful in all patients. There were no newly-developed neurological deficits during the 6-month clinical follow-up period. One patient did not receive follow-up imaging due to pregnancy. Nine patients with 12 aneurysms received a 6-month angiographic follow-up. Ten aneurysms (83.3%) showed decreases in volume greater than 50% (mean volume decrease, 82.8 ± 32.9%), of which 8 (66.7%, 95% confidence interval, 35.4-98.0%) showed complete occlusion. One patient was retreated due to mass symptom aggravation. Conclusions: In this pilot study, FloWise appeared to be safe and effective for ICA aneurysm treatment. A prospective multicenter study to validate the effectiveness and safety of FloWise would be worthwhile.
Bibliographical noteFunding Information:
Received July 3, 2018; accepted after revision October 17, 2018. This study was supported by grants of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry for Health & Welfare, Republic of Korea (grant numbers HI08C2149 and HC151056). Corresponding author: Byung Moon Kim, MD, PhD, Department of Radiology, Yonsei University College of Medicine, Severance Stroke Center, Severance Hospital, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea. • Tel: (822) 2228-7400 • Fax: (822) 393-3035 • E-mail: email@example.com This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https:// creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
All Science Journal Classification (ASJC) codes
- Radiology Nuclear Medicine and imaging